Autoantibodies Prevalence During Checkpoint Inhibitor Treatment

NCT04220034 | Completed

• 1 other identifier: PA19123*
• Study Type: observational
• Target: 183
• Locations: 1 country
• Sites: 1

Brief Summary

The use of Checkpoint inhibitors (ICIs) is rapidly expanding to the treatment of many cancer types. Autoimmunity and clinical autoimmune diseases represent adverse events of ICIs with variable severity and consequences. Clinical trials using ICIs have largely excluded patients with preexisting autoimmune diseases but the rate of autoimmune flares has been reported to be high in patients with preexisting autoimmune diseases in retrospective cohort studies. Moreover numerous retrospective cases and series reported ICI-related autoimmune diseases in patients without any previous autoimmune event. To date, no study has prospectively evaluated the rate of biological and clinical autoimmunity in patients. Moreover, guidelines concerning autoantibodies monitoring in patients are subject of debate.

Conditions

Autoimmune Adverse Effects of Anti-neoplasic Drug

Outcome Measures

Primary Outcomes (6)

• development or increase level of anti-nuclear antibody

  Development of anti-nuclear antibody will be defined by detection of autoantibodies above the positive threshold of the test if below the positive threshold initially (seroconversion) Increase level of anti-nuclear antibody will be defined by increase of at least 2 dilutions of the antibody titer

  Month 6

• development or increase level of anti-cyclic citrullinated peptide antibodies

  Development of anti-cyclic citrullinated peptide antibodies will be defined by detection of autoantibodies above the positive threshold of the test if below the positive threshold initially (seroconversion) Increase level of anti-cyclic citrullinated peptide antibodies will be defined by doubling the concentration of the antibody titer

  Month 6

• development or increase level of rheumatoid factor

  Development of rheumatoid factor will be defined by detection of autoantibodies above the positive threshold of the test if below the positive threshold initially (seroconversion) Increase level of rheumatoid factor will be defined by doubling the concentration of the antibody titer

  Month 6

• development or increase level of Anti-glutamic acid decarboxylase antibodies

  Development of Anti-glutamic acid decarboxylase antibodies will be defined by detection of autoantibodies above the positive threshold of the test if below the positive threshold initially (seroconversion) Increase level of Anti-glutamic acid decarboxylase antibodies will be defined by doubling the concentration of the antibody titer

  Month 6

• development or increase level of Anti-thyroperoxydase antibodies

  Development of anti-TSH receptor antibodies will be defined by detection of autoantibodies above the positive threshold of the test if below the positive threshold initially (seroconversion) Increase level of anti-TSH receptor antibodies will be defined by doubling the concentration of the antibody titer

  Month 6

• development or increase level of Auto-antibodies associated with myositis

  Development of Auto-antibodies associated with myositis antibodies will be defined by detection of autoantibodies above the positive threshold of the test if below the positive threshold initially (seroconversion) Increase level of Auto-antibodies associated with myositis antibodies will be defined by doubling the concentration of the antibody titer

  Month 6

Study Arms (1)

Patients receiving inhibitor checkpoint treatment

adult patients that will receive for the first time checkpoint inhibitor for a neoplasic disease in a center participating to the study

Biological: Blood sample

Interventions

Blood sample BIOLOGICAL

Blood sample will be collected to determine development or increase level frequencies of different types of autoantibodies in patients receiving ICI for the first time

Patients receiving inhibitor checkpoint treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients receiving inhibitor checkpoint treatment

You may qualify if:

• patients who agree to participate in the study
• adult patients (aged more than 18 years old)

You may not qualify if:

• \- previous treatment with check point inhibitor

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Chu Reims

Reims, 51092, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood sample

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2020
• First Posted: January 7, 2020
• Study Start: January 15, 2020
• Primary Completion: July 22, 2024
• Study Completion: November 28, 2025
• Last Updated: December 2, 2025

Record last verified: 2025-11

Locations

FR (1)